Maltofer Syrup Uses Side-effects Dose In Urdu

Maltofer Syrup Uses Side-effects Dose In Urdu

Maltofer Syrup Uses Side-effects Dose In Urdu

( iron(lll)- hydroxide polymaltose complex)
Syrup, 10mg/ml
Oral Drops, 50mg/ml
CLINICAL PARTICULARS:

Maltofer Syrup Uses

Maltofer syrup Uses and maltofer oral drops
Treatment of iron deficiency without anemia and iron deficiency anemia.
Prophylactic therapy of iron deficiency.
Prophylactic therapy of iron deficiency during pregnancy.

Maltofer Syrup Dose AND METHOD OF ADMINISTRATION:

Maltofer Syrup Dose
Treatment of iron deficiency anemia in children and adults: The therapy takes about 3 to 5 months until normalization of the hemoglobin (HB) value is achieved. Afterward. The therapy should be continued for several weeks with a dosage such as described for iron deficiency without anemia to replenish the iron stores.
Treatment of iron deficiency anemia during pregnancy: The therapy should be continued until normalization of Hb values is achieved. Afterward, the therapy should be continued at least until the end of the pregnancy with a dosage such as described for iron deficiency without anemia to replenish iron stores and to supplement the increased iron need during pregnancy.
Treatment and prevention of iron deficiency without anemia: The therapy about 1 to 2 months.

METHOD OF ADMINISTRATION:

The daily dose can be divided into separate doses or can be taken at once. Maltofer should be taken during or immediately after a meal. Maltofer food.
The slight discoloration of the mixture does not affect either the taste of the juice/ baby food or the efficacy of maltofer.
The ensure accurate dosing of maltofer drops the bottle needs to be held perpendicular The drops should flow immediately. If this does not happen, tap the bottle gently until a drop forms. Do not shake the bottle.
SPECIAL DOSAGE INSTRUCTIONS:
There is either no or only very limited clinical data from clinical studies available for the use of maltofer in patients population with a history or evidence of significant gastrointestinal disorders, with hepatic impairment, or renal impairment, and in elderly patients taking into consideration the knowledge about the efficacy and safety of maltofer Syrup In Urdu It from post-marketing experience, there is no evidence to suggest that the safety and efficacy profile of maltofer is different in these patients, thus no special dosage recommendations are needed for these patients populations.
CONTRAINDICATIONS:
The use of maltofer is contraindicated in the following cases:
Known Hypersensitivity to IPC or to any of the excipients.
Iron overload such as hemochromatosis, haemosiderosis.
Disturbances in iron utilization ( such as anemia from lead poisoning, sideroachrestic anemia, thalassemia).
Anemia is caused by iron deficiency such as hemolytic anemia or megaloblastic anemia due to vitamin B12 deficiency.

WARNINGS AND PRECAUTIONS

GENERAL WARNINGS AND PRECAUTIONS:
During treatment with maltofer there may be dark discoloration of the faeces (stool), however this is of no clinical relevance.
Infections or tumors may cause anemia. Since iron can be utilized only after correcting the primary disease, a benefit/risk evaluation is advisable.
The intake of maltofer drops is not expected to have an impact on the daily insulin management of diabetes patients.Maltofer syrup contains 200mg of sucrose per ml.
This should be taken into account in patients, with diabetes mellitus.
warning
Sodium methyl hydroxybenzoate (E219) & sodium propyl hydroxybenzoate (E217) in maltofer syrup and drops may cause allergic reactions (possibly delayed).
Maltofer syrup and drops contain sucrose. Patients with rare hereditary problems of fructose intolerance to some sugars or if you have been diagnosed with cannot break down fructose, talk to your doctor before you (or your children) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Maltofer syrup contains 1mg sodium (main components of cooking/table salt) in Each ml.
This is equivalent to 0.05% of the recommended maximum daily dietary intake of sodium for adults.

DRUG ABUSE AND DEPENDENCE:

No data are available.
ABILITY TO DRIVE AND USE MACHINES:
No relevant studies have been conducted. However, it is unlikely that maltofer has any effect on the ability to drive and use machines.
LABORATORY TESTS:
Maltofer can cause Discolored (black) stool may visually mask gastrointestinal bleeding. However the haemoccult test (selective for Hb) for the detection of occult blood is not impaired, and therefore there is no need to interpret the therapy.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:

Interactions of IPC with tetracycline or aluminum hydroxide were investigated in 3 human studies (crossover design, 22 patients per study) No significant reduction in the absorption of tetracycline was observed. The plasma tetracycline concentration did not fall below the minimum inhibitory concentration levels necessary for bacteriostasis. Iron absorption from IPC was not reduced by aluminum hydroxide or tetracycline.IPC can therefore be administered at the same time as tetracycline or other phenolic compounds as well as aluminum hydroxide.
The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to interpret the therapy.
Concomitant administration of parenteral iron and maltofer is not recommended Since the absorption of oral would be reduced.

USES IN SPECIAL POPULATIONS

PREGNANCY:
No data from clinical studies are available on the use of IPC products in pregnant women during the first trimester. To date, there have been reports of serious adverse reactions after ingestion of IPC at therapeutic doses for the treatment of anemia in pregnancy. Animal data on IPC showed no evidence of risk to fetus and mother.
Studies in pregnant women after the first trimester have not shown any undesirable effects of IPC in mothers and/ or neonates.
Therefore a negative influence on the fetus is unlikely with the administration of maltofer.
As a precautionary measure, women of childbearing age and women during pregnancy should only use maltofer after consulting a medical doctor or pharmacist. A benefit/risk evaluation is available.
LABOR AND DELIVERY.
No data are available.

NURSING MOTHERS:

Human breast milk naturally contains iron which is bound to lactoferrin. The amount of iron passing IPC to the mother’s milk is unknown. It is unlikely that the administration of maltofer Syrup In Urdu It Use in women who are breastfeeding causes undesirable effects to the infant.
As a precautionary measure during lactation, maltofer should only be used after consulting a medical doctor and or pharmacist. A benefit/risk evaluation is advisable for undesirable effects.

UNDESIRABLE EFFECTS FROM CLINICAL TRIALS (PRE AND AUTHORIZATION, INCLUDING POST AUTHORIZATION SAFETY STUDIES).

The safety and tolerability of maltofer have been evaluated in a meta-analysis of 24 publications or clinical study reports encompassing a total number of 1473 exposed patients.
The principal adverse drug reactions that have been reported in these trials, occurred in 4 system organ classes.
Discolored feces are well-known adverse drug reactions of oral medications, but this is considered of no clinical relevance and is under-reported. Other commonly seen side effects were gastrointestinal disorders ( nausea, constipation and diarrhea, and abdominal pain).

Side-effects

1- Faeces Discolored were reported with less frequency in the meta-analysis but are a well-known drug-related effect of iron therapy in general. Therefore it has been allocated to the very common frequency of undesirable effects.
2- includes abdominal pain, dyspepsia, epigastric discomfort, abdominal distention.
3- includes vomiting, regurgitation.
4- includes muscle contractions involuntary, tremors.
5- includes rash, rash macular, rash vesicular.
6- Events originating from post-marketing spontaneous reporting, the estimated incidence of <1/491 patients ( upper limit of 95% confidence interval)
UNDESIRABLE EFFECTS FROM POST MARKETING SPONTANEOUS REPORTING:
No additional adverse drug reactions were identified.
LABORATORY ABNORMALITIES:
No data are available.

OVERDOSE:

In case of overdose, intoxication or iron accumulation are unlikely with maltofer due to the low toxicity of IPC (i.e in mice or rats: lethal dose 50% mg (LD50) >2000mg Fe/kg body weight) and controlled uptake of iron. No cases of accidental poisoning with fatal outcomes have been reported.

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